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Elizabeth M. Topp Lecture in UL 16th Oct 12:00 (ssHDX-MS)

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University of Limerick

Pharmaceutical Manufacturing Technology Centre

Bernal Research Institute

V94 T9PX Castletroy

Ireland

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Solid-state hydrogen deuterium exchange (ssHDX-MS) in the development of lyophilized protein formulations

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Many protein drugs are marketed as lyophilized solid powders. To develop the product, candidate formulations are evaluated in stability studies that can take years to complete. While physicochemical analyses (e.g. FTIR, Tg) provide information about the properties of the solid, they are usually poorly correlated with storage stability. There is a need for a stability-indicating analytical method for protems in Iyophilized powders and other amorphous solids.

Our group has developed solid-state hydrogen deuterium exchange with mass spectrometric analysis (SSHDX-MS) as a novel analytical method for proteins in lyophilized solids, providing high resolution information on protein structure and matrix interactions. We have shown that SSHDX-MS is sensitive to changes in formulation, moisture content and processing method. SSHDX-MS has also been shown to be highly correlated with the storage stability of various formulations of myoglobin (Mb) and of a monoclonal antibody (mAb). SSHDX-MS thus shows promise as a stability-indicating method that could help accelerate the development of Iyophilized protein drugs.

This presentation will provide an overview of the SSHDX-MS method and summarize results demonstrating correlation of ssHDX-MS metrics with the storage stability of several lyophilized proteins. Ongoing studies, directed toward establishing a mechanistic model for SSHDX-MS, will also be presented.

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University of Limerick

Pharmaceutical Manufacturing Technology Centre

Bernal Research Institute

V94 T9PX Castletroy

Ireland

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